The Effect of Oral Carnitine Supplementation on MRS-derived Mitochondrial Function
Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Elderly; Pre-diabetic
Intervention: Acute Exercise (Other); Acute Exercise (Other)
Phase: N/A
Status: Completed
Sponsored by: Duke University Official(s) and/or principal investigator(s): William E Kraus, MD, Principal Investigator, Affiliation: Duke University
Summary
This is a longitudinal study supported by Pfizer and is a collaboration between DMPI (Duke
Molecular Physiology Institute) and DIAL (Duke Image Acquisition Laboratory) to measure the
effects of acute exercise on carnitine and acylcarnitine levels in the muscle and on insulin
sensitivity in the plasma. This pilot study seeks to explain why moderate intensity
exercise provides more improvements in glucose control for pre-diabetic patients than
vigorous intensity. The investigators hypothesize that moderate intensity exercise might be
beneficial for elderly individuals who are overweight or obese, specifically by: 1. Reducing
damaging excess protein acetylation (measured in muscle biopsy), 2. Improving the
acylcarnitine/carnitine ratio (measured by MRS), 3. Improving overall mitochondrial function
as reflected in reduced phosphocreatine recovery time (measured by MRS) and 4. Increasing
insulin sensitivity as measured by a 4-hour oral glucose tolerance test. Investigators
intend to use the results of this study to show feasibility in measuring mitochondrial
function at Duke for a larger federal grant submission. Investigators hypothesize that
carnitine insufficiency might contribute to mitochondrial dysfunction and obesity-related
impairments in glucose tolerance and insulin action.
Clinical Details
Official title: The Effect of Oral Carnitine Supplementation on MRS-derived Mitochondrial Function
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in Acylcarnitine/Carnitine ratio
Secondary outcome: Change in Protein acetylationChange in Insulin Sensitivity Change in Mitochondrial Function
Eligibility
Minimum age: 60 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age: 60-80 years
- Moderately Overweight: BMI - 25. 0 - 35. 4
- Sedentary - exercise ≤ 1 day/week
- Fasting plasma glucose: > 100 - < 126 mg/dL
- Readings from two separate days
Exclusion Criteria:
- Orthopedic limitations, musculoskeletal disease and/or injury
- Allergic to xylocaine
- Inability to give blood continuously through an intravenous catheter
- Have a confounding medical condition that is progressive and unstable such as HIV,
Hepatitis C, active cancer, and/or taking medications for those conditions that are
likely to confound the assessment of pre-diabetes
- Prior surgical operation within the past 6 months
- Prior injury to the eye involving metallic objects or fragments
- Prior injury involving a metallic object or foreign body (eg. BB, bullet, shrapnel,
etc.)
- Tattoos from the waist down to the feet
- Any of the following implants or devices
- Aneurysm clip
- Cardiac pacemaker
- Implanted cardioverter defibrillator (ICD)
- Electronic implant or device
- Magnetically activated implant or device
- Neurostimulation system
- Spinal cord stimulator
- Internal electrodes or wires
- Bone growth/bone fusion stimulator
- Cochlear, otologic or other ear implant
- Insulin or other infusion pump
- Implanted drug infusion device
- Eye implants
- Vascular access port and/or catheter
- Wire mesh implant or stent
- Other implant
- Claustrophobia
- Prior knee replacement surgery
- Pregnant or intending to become pregnant during the study
Locations and Contacts
Duke Center for Living, Durham, North Carolina 27710, United States
Additional Information
Starting date: June 2014
Last updated: June 15, 2015
|